Evidence map›Paper›PMID 40917693›Full record

ArticleMolecular therapy. Methods & clinical development2025

Development and implementation of an LC-MS-based multi-attribute method for adeno-associated virus.

Thomas W Powers, Shawn Mariani, Halyna Narepekha, Daniel Ryan, Savita Sankar, Thomas F Lerch

Abstract read
In one paragraph

Article in Molecular therapy. Methods & clinical development, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Thomas W PowersPfizer Inc., Analytical Research and Development, 875 Chesterfield Pkwy. West, Chesterfield, MO 63017, USA.
Shawn MarianiPfizer Inc., Analytical Research and Development, 875 Chesterfield Pkwy. West, Chesterfield, MO 63017, USA.
Halyna NarepekhaPfizer Inc., Analytical Research and Development, 875 Chesterfield Pkwy. West, Chesterfield, MO 63017, USA.
Daniel RyanPfizer Inc., Analytical Research and Development, 875 Chesterfield Pkwy. West, Chesterfield, MO 63017, USA.
Savita SankarPfizer Inc., Analytical Research and Development, 875 Chesterfield Pkwy. West, Chesterfield, MO 63017, USA.
Thomas F LerchPfizer Inc., Analytical Research and Development, 875 Chesterfield Pkwy. West, Chesterfield, MO 63017, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The multi-attribute method (MAM), a mass spectrometry technique for quantifying amino acid modifications at the peptide level, is becoming a prominent analytical tool in the development of biotherapeutics. The method has promise for adeno-associated virus (AAV) therapeutics, where capsid protein modifications have been directly linked to reduced transduction efficiency. Given this link, a robust and precise procedure to quantitate capsid modifications would be beneficial for implementation throughout biotherapeutic development. Herein, an AAV product was characterized, and capsid sequence liabilities were identified. A peptide map MAM method was developed to quantitate select sites of modifications and was validated according to ICH Q2(R2). Through this exercise, the method was demonstrated to be suitable to quantitate several sites of deamidation and the method was applied during stability, process development, and product comparability studies. Additionally, preliminary data demonstrated that the method was not limited to monitoring deamidation but also could be applied to other post-translational and chemical modifications.

Indexed as

adeno-associated virus, AAVcapsid deamidationcapsid modificationsgene therapymulti-attribute method

Identifiers

PMID40917693
PMCPMC12410397

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.